About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children’s HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).
The Harmony system first received FDA clearance in March 2021. However, the FDA designated a Class I recall for the system in April 2022 after Medtronic reported that the bond holding the capsule at the end of the delivery catheter could break during TPV placement.
Medtronic relaunched Harmony in the U.S. in February 2023 and soon had positive two-year results to report for the system.
With 2,200 people already implanted with the Harmony valve, the new regulatory approval in the European Union should make it even more widely available.
“The expansion of the Harmony TPV system enables a critical new solution, ensuring that more patients can have access to cutting-edge transcatheter technology and potentially lessen the need for multiple surgeries,” Nina Goodheart, SVP and president of Medtronic’s Structural Heart & Aortic business, said in a news release.
“This significant milestone underscores our unwavering commitment to delivering minimally invasive treatment options with excellent safety and effectiveness to patients and physicians worldwide.”
For the 80% of congenital heart disease patients who need a native or surgically repaired RVOT at birth, many will need a pulmonary valve replacement later in life, according to Medtronic. The valve replacement has often meant another open-heart surgery.
“Receiving CE Mark for the Harmony TPV system helps advance options for minimally invasive solutions for physicians to treat this vulnerable patient population and optimize their outcomes,” said Dr. Peter Ewert, a professor and director of the Department of Congenital Heart Defects and Pediatric Cardiology at the German Heart Center in Munich, Germany.
“Clinicians across Europe are in need of solutions to fill this gap, and this milestone will be a potential turning point for patients who want to avoid multiple surgeries and minimize medical disruptions in their daily lives.”
